Who am I? Am I still an importer, already a distributor or even the manufacturer myself? These are the questions many medical device companies and their partners are asking themselves, since the roles and obligations of the economic actors within the medical technology industry have been redistributed or defined for the first time in the MDR, which will soon come into force. This also includes the role of the importer. This is subject to its own set of obligations and associated liability risks. Importers must even assume the duties of the manufacturer in special cases.
Who is an importer according to the MDR?
“Importer” means any natural or legal person established in the Union who places a product from a third country on the Union market.”
What do I need to do? General obligations of importers are regulated in Article 13 of the MDR. Here, not only the obligations regarding product conformity, but also the relationships between importers and other economic operators are specified. In addition to Article 13, all requirements directed at economic operators apply.
Verify, notify and cooperate
The interaction between importer, competent authorities and other actors can be structured as follows:
The importer must verify that the manufacturer has fulfilled its obligations. For this purpose, the following information must be available:
The validity and correctness of the CE marking and the EU declaration of conformity for the product (Article 13 (2)).
The indication of the manufacturer on the product (Article 13 Par. 2)
The indication of the authorized representative in accordance with Article 11 of the MDR on the product (Article 13(2)).
The labeling of the device and the instructions for use in accordance with MDR (Article 13, para. 2)
The UDI in accordance with Article 27 of the MDR (Article 13(2)).
The registration of the product in the electronic system according to Article 29 of the MDR (currently via DIMDI/BfArM) and the supplementation of the registration with own data according to Article 31 of the MDR (Article 13 para 4).
The importer must report and/or inform about the following:
If the product does not comply with the requirements of the MDR, the importer must not place the product on the market until the product has been brought into compliance. The manufacturer and the authorized representative must be informed (Article 13(2)).
In case of high risk probability or counterfeit products, the competent authority of the Member State shall be informed (Article 13(2)).
Keep a register of complaints, non-conforming products and recalls and withdrawals and make it available to the manufacturer/authorized representative (Article 13 (6)).
In case of non-conformity of a product placed on the market by the importer, the manufacturer and, if applicable, his authorized representative shall be informed immediately (Article 13 (7)).
In the event of a serious likelihood of danger, the competent authorities of the Member States in which the importer makes the device available and, if applicable, the competent Notified Body shall be informed without delay (Article 13 (7)).
Immediate notification of the manufacturer and the authorized representative of suspected incidents related to the device (Article 13 (8)).
For at least ten years after the last device has been placed on the market (15 years for implantable devices), notification to the competent authority of all economic operators/health care facilities/health care professionals to whom the device was directly supplied and all economic operators from whom the device was directly obtained (Article 25(2))
The importer must cooperate to the following extent:
With the manufacturer, the authorized representative, with the competent authorities in all preventive or corrective actions, recalls and withdrawals (Article 13, paragraph 7)
With the competent authorities in all measures to prevent or mitigate hazards (Article 13(10)); to provide free samples of the product or the product at the request of the competent authority; if this is not readily practicable, to provide access to the product (Article 13(10))
With distributors to become aware of any non-conformities of the product and to be informed of any preventive or corrective actions, recalls and withdrawals by the distributor (Article 14(4)); to become aware of any suspected incidents related to the product (Article 14(5)) and to become aware of the register kept by other distributors regarding complaints, non-conforming products and recalls and withdrawals (Article 14(5))
With the distributors and manufacturers to ensure the traceability of the product (Article 25 par. 1)
With the competent authority, if the authority has identified an unacceptable risk or non-conformity as a result of market surveillance activities (Article 94), the importer shall ensure that all appropriate corrective action is taken in respect of the products made available on the market (Article 95(3))
Labeling, transport, storage and documentation
Importer’s information on the product’s labeling, packaging or accompanying documents (name, registered trade name or registered trademark, registered place of business and the address) without obscuring the manufacturer’s labeling (Article 13(3))
observance of storage and transport conditions in accordance with the manufacturer’s specifications while a product is under the responsibility of the importer (Article 13(5))
Retention of documentation for at least ten years after the product was last placed on the market, and at least fifteen years in the case of implantable devices, (EU declaration of conformity, certificate, amendments and supplements) (Article 13(9))
Electronic system for registration of economic operators currently via DIMDI/BfArM in Germany, later Europe-wide Eudamed (some data publicly available):
The importer registers in the electronic system according to Annex VI Part A Section 1 (Article 30 para. 1, Article 31 para. 1).
If a Notified Body is involved in the conformity assessment procedure, registration must take place before the application is submitted to the Notified Body (Article 31(1)).
After the assessment, the importer receives a unique registration number (“SRN” – Single Registration Number) from the competent authority (Article 31 (2)).
Attention. The module for obtaining the SRN will go live on December 1, 2020!
The importer checks the registration of the manufacturer/authorized representative in the electronic system and the entered information within two weeks after placing the product on the market (Article 30 (3)).
If the data entered in the system changes, the importer must update the data within one week (Article 31(4)).
When an economic operator changes, the Competent Authority must be informed and the data in the electronic system updated accordingly. The economic operators are to clarify among themselves who assumes the notification obligation in order to ensure identification within the supply chain (Article 25).
No later than one year after the first submission and every two years thereafter, the importer shall confirm the accuracy of the data (Article 31(5)).
Liabilities
The importer is liable for defective products if the manufacturer established outside the Union has not fulfilled its general obligations (recital 35).
The importer is jointly and severally liable with the authorized representative and the manufacturer (Recital 35).
When do the manufacturer obligations under Chapter 16 of the MDR apply to the importer?
When performing any of the following activities, the importer assumes the obligations of the manufacturer (para.1):
Making a product available on the market under the importer’s own name, for example when the importer’s own brand is applied or the manufacturer is not explicitly identified (exception: an agreement with the manufacturer whereby the manufacturer is identified as such on the label and is responsible for compliance with the MDR requirements applicable to manufacturers);
Change of intended purpose of a device placed on the market;
Modification of a device already placed on the market in a manner that could affect compliance (Exceptions: Provision including translation of accompanying documentation, change of packaging/repackaging without damaging the original condition).
If any of these activities are performed by the importer, the importer assumes further obligations:
In case of changes in information or packaging, the importer shall indicate on the product, on the packaging and/or on the accompanying documents his name, registered trade name or registered trade mark, registered place of business and address (para. 3).
The importer must have a QMS for the procedures with the activities performed, including procedures to ensure that he is informed of any corrective actions by the manufacturer (Para. 3).
At least 28 days before the relabeled or repackaged product is placed on the market, the importer shall inform the manufacturer and the competent authority of his intention (par. 4).
If applicable, he must provide the manufacturer and the competent authority with a sample or model upon request, including the translated labeling and translated instructions for use (par. 4).
What am I not responsible for as an importer?
The importer is not responsible for ensuring the correctness of the product conformity assessment procedure, i.e. document and label verification is mainly the responsibility of the manufacturer and his authorized representative (Article 11, 3a).
If an authority of the Member State in which the authorized representative has its registered place of business requests a sample of or access to a product, the importer does not have to forward this request to the manufacturer or verify that the competent authority receives the samples or access to the product (Article 11, 3e).
The importer is not liable for defective products on the same basis as the manufacturer (Article 11, 5).
The importer is not responsible for terminating the mandate if the manufacturer breaches its obligations under the MDR (Article 11, 3h) and for informing the competent authority of this without delay (Article 11, 6).
He is not responsible for applying for a certificate of free sale for export purposes (Article 60, 1).
The importer does not need permanent access to a qualified professional responsible for regulatory compliance (Article 15, 6).
All of these described responsibilities rest with the authorized representative. Even though the listed duties are not the responsibility of the importer, the importer must ensure that there is an authorized representative to perform these duties.
Still looking for your role in the MDR? Have you perhaps acted as a distributor so far, but perhaps see yourself more as an importer? Have you been approached by a non-European company about import opportunities? But you did not have regulatory requirements in your offer catalog so far? We are happy to offer you the necessary regulatory support for an MDR compliant QMS for you as an importer. Simply contact us without obligation.
Please note that all information and listings do not claim to be complete, are without guarantee and are for information purposes only.
